Arrhythmia Research Technology, Inc. Announces Research Agreement and Participation in National Institutes of Health Investigat
31 Mayo 2006 - 7:57AM
Business Wire
Arrhythmia Research Technology, Inc. (the "Company" or "ART")
(AMEX: HRT) is pleased to announce that it has entered into a
Research Agreement with the University of Rochester, Rochester, New
York, to participate in a National Institutes for Health ("NIH")
funded investigation into "Risk Stratification in MADITT II Type
Patients". The primary objectives of this study are: 1. To evaluate
the predictive value of a multivariate model consisting of
pre-specified clinical and ECG parameters for predicting arrhythmic
events in Multicenter Automatic Defibrillator Implantation Trial II
("MADIT II") type post-infarction patients; 2. To develop a
multivariate risk-stratification model, based on a broader spectrum
of pre-specified clinical covariates and ECG parameters, and from
it a risk-scoring algorithm identifying high-risk and low-risk
patient groups; this algorithm will be validated by a
cross-validation study. Such an algorithm will enable an ordering
of patients who may benefit most, and benefit least, from
implantable cardiac defibrillator ("ICD") therapy. Based on
previous experience from MADIT II, this study will investigate a
combination of clinical variables and noninvasive ECG parameters
which will indicate the contribution of different
electrophysiological mechanisms that predispose a patient to the
risk of ventricular arrhythmias and sudden cardiac death. ART's
patented signal averaging electrocardiogram ("SAECG") analysis
software will be used to assess the presence of cardiac late
potentials in patients enrolled in the study in conjunction with
other non-invasive cardiac tests. The Principal Investigator for
the NIH study, Wojciech Zareba, MD, PhD, of the University of
Rochester, plans to enroll approximately 800 patients at over 20
medical research centers over the next 24 months. The study will
focus on patients who currently receive ICD's for MADITT II
indications while excluding patients with atrial fibrillation, a
paced ventricular rhythm, a QRS duration greater than 120ms, and
New York Heart Association class III heart failure who are
candidates for resynchronization therapy. Follow up on these
patients will occur over the next three years. Dr. Zareba, who has
used the ART's patented Predictor(R) signal averaging software
extensively, commented, "Signal averaged ECG with detailed analysis
of QRS duration and late potentials is a very valuable tool in
stratifying patients at risk of cardiac death. MADIT II type
patients with normal QRS duration and lack of late potentials are
at relatively low risk of subsequent cardiac events. The very high
negative predictive value of SAECG might help prioritize patients
for ICD therapy. We are glad to have the opportunity to test the
predictive value of SAECG in a prospective cohort of MADIT II type
patients who are undergoing several other tests simultaneously. It
is likely that SAECG and Microvolt T-Wave Alternans tests will
emerge as routine for identifying low-risk and high-risk patients
considered for ICD therapy." A signal-averaged electrocardiogram
detects cardiac microvolt signals. Signal averaging, which improves
the signal to noise ratio, is a well-recognized technique for
detecting and analyzing such cardiac microvolt signals. High
resolution acquisition equipment is used to collect the microvolt
signals and transfer the data to an analytical system. Software,
such as ART's patented Predictor(R) software, embedded in the
device then analyzes and filters the data to present the signal
averaged ECG for interpretation by a cardiologist. ART's
participation, in accordance with the Research Agreement, will be
to provide hardware (ART 1200 EPX) and software - including the
Windows(R) based Predictor(R) SAECG analysis - to support the
signal averaged ECG aspect of this study. In addition, ART is
providing monetary support for the expenses associated with the
acquisition of the signal averaged ECG and the analysis of the
data. James E. Rouse, the Company's President and CEO stated, "We
are extremely pleased to be a part of this NIH funded
investigation. We are honored that Dr. Zareba has chosen the
Company's 1200 EPX hardware and Predictor(R) software for use in
this NIH investigation which we hope will produce life altering and
life saving benefits for post-infarction patients. The inclusion of
ART's proprietary SAECG technology products in this study as one of
the clinical variables to stratify the risk of arrhythmias and
sudden cardiac death for the purpose of identifying patients with
increased benefit from implantable cardiac defibrillator therapy is
a significant event for the Company. The Company's SAECG software
platform has long been recognized as the "gold standard" in signal
averaging. We are excited about the market prospects for the
Windows(R) version of Predictor(R) SAECG analysis software as ICD
therapy becomes more prevalent and cost becomes a greater concern.
" In addition to its proprietary SAECG software used in the
detection of potentially lethal heart arrhythmias the Company,
through its wholly owned subsidiary, Micron Products Inc., produces
silver plated and non-silver plated conductive resin sensors and
distributes metal snaps used in the manufacturer of disposable ECG,
EEG, EMS and TENS electrodes. Micron's NEM division manufactures
custom injection molded products for medical, electronic,
industrial and consumer applications. Micron's MIT division
provides end-to-end product life cycle management through a
comprehensive portfolio of value-added services such as design,
engineering, prototyping, manufacturing, machining, assembly and
packaging. For more information please visit our websites:
http://www.arthrt.com http://www.newenglandmolders.com
http://www.micronproducts.com http://www.micronintegrated.com
Forward-looking statements made herein are based on current
expectations of the Company that involve a number of risks and
uncertainties and should not be considered as guarantees of future
performance. The factors that could cause actual results to differ
materially include: interruptions or cancellation of existing
contracts, impact of competitive products and pricing, product
demand and market acceptance, risks, the presence of competitors
with greater financial resources than the Company, product
development and commercialization risks, changing economic
conditions in developing countries, and an inability to arrange
additional debt or equity financing. More information about factors
that potentially could affect the Company's financial results is
included in the Company's filings with the Securities and Exchange
Commission, including its Annual Report on Form 10-KSB for the year
ended December 31, 2005.
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